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WO1994027656A1 - Dispositif de gastrostomie avec une valve de non-retour fendue transversalement - Google Patents

Dispositif de gastrostomie avec une valve de non-retour fendue transversalement Download PDF

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Publication number
WO1994027656A1
WO1994027656A1 PCT/US1994/005221 US9405221W WO9427656A1 WO 1994027656 A1 WO1994027656 A1 WO 1994027656A1 US 9405221 W US9405221 W US 9405221W WO 9427656 A1 WO9427656 A1 WO 9427656A1
Authority
WO
WIPO (PCT)
Prior art keywords
dome
valve
shaft
cylindrical body
wall
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US1994/005221
Other languages
English (en)
Inventor
Donald Jay Goldhardt
William Henry Hirsch
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Laboratories
Original Assignee
Abbott Laboratories
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Abbott Laboratories filed Critical Abbott Laboratories
Priority to CA002162043A priority Critical patent/CA2162043C/fr
Priority to EP94916731A priority patent/EP0701454A4/fr
Publication of WO1994027656A1 publication Critical patent/WO1994027656A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/003—Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A61J15/0034—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters
    • A61J15/0038—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters expandable, e.g. umbrella type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/0053—Means for fixing the tube outside of the body, e.g. by a special shape, by fixing it to the skin
    • A61J15/0065—Fixing means and tube being one part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/0092—Valves on feeding tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0015—Gastrostomy feeding-tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0213—Holding devices, e.g. on the body where the catheter is attached by means specifically adapted to a part of the human body
    • A61M2025/0233—Holding devices, e.g. on the body where the catheter is attached by means specifically adapted to a part of the human body specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall

Definitions

  • the invention relates to a gastrostomy device for insertion into a stoma in replacement of a gastrostomy device that has been removed intentionally or accidentally.
  • Gastrosto ies now assume a key role in the management of patients with swallowing difficulties due to injury or disease, as well as those patients requiring long term enteral feedings.
  • a catheter usually of the de Pezzer or Foley type.
  • these catheters have several disadvantages and are associated with a variety of complications, such as, internal or external migration, inadvertent removal, pivoting action leading to leakage and tissue reaction.
  • Each of these devices has a shaft in the form of a short tube or conduit extending from an inner bulb or dome, often of mushroom-like shape resembling the tip of a de Pezzer catheter, and with one or more perforations for liquid passage, to an external or outer portion that is self-retaining, e.g., with flat wings or a ridged or perforated flat flange.
  • a valve usually at the gastric opening of the shaft, prevents external reflux of intragastric contents.
  • a small cap or plug at the skin level is removed and a simple hollow adapter is inserted into the shaft for feeding. The valve may have low opening pressure or the adapter may be inserted through the valve. Feeding accomplished, the tube or shaft is flushed with water, the adapter removed, and the cap or plug replaced.
  • U.S. Patent 4,315,513 describes a gastrostomy or transport tube of the type referred to above, in this case with a check valve, i.e., a one-way valve, within the shaft with a valve stem attached to a hemispherical element that seats into a mating cavity when there is pressure within the stomach, with the valve stem extending through the bottom of the seat as a guide.
  • a check valve i.e., a one-way valve
  • a hemispherical bulb or dome of a soft rubber that is diametrically slit so that no internal check valve is needed.
  • the wall of the bulb or dome is of uniform thickness similar to that of the wall of the shaft employed.
  • U.S. Patent 4,863,438 there is described a low profile gastrostomy device of the type referred to above with a hollow bulb-like internal retaining element with apertures for passage of fluids and with a flat flapper valve serving as a check valve.
  • the flapper valve extends across the end of the shaft within the bulb-like retaining element.
  • the bulb-like portion is of uniform wall thickness, the bottom portion being integrally formed with the shaft and the top portion being adhesively bonded to the bottom portion.
  • the shaft at its outer or skin end is closed by a plug that is attached by a flexible membrane to the edge of one of the pair of flat wings or a flange that serves as the external retaining element.
  • the one-way valve employed in the invention is a cross-slit duckbill valve formed of an elasto eric material of the type generally described in U.S. Patent 5,261,459.
  • a valve has a foreshortened hollow cylindrical body with first and second ends and an axis and with the passageway through the cylindrical body entirely controlled by a transversely extending continuous ridge and valley web or wall structure with intersecting slits in a centrally located intersection of the ridges substantially at the axis.
  • the ridge and valley web consists of two wall portions, each partially folded along a line, the lines constituting the ridges or apices, each wall portion being V-shaped in section, and each wall portion extending substantially diametrically of the cylindrical body and normal to each other with the V's both opening in the same axial direction of the cylindrical body towards the first end thereof, and, with the lines formed by the apex of each folded wall portion meeting at about right angles to form four quadrants, each wall portion ending midway around a quadrant where it meets and merges with and is integrally joined to the mutually intersecting wall portion to form a valley extending radially outwardly from the intersection of the apices at about the axis of the cylindrical body as well as at an angle from the apices toward the direction of the first end of the cylindrical body, the so-shaped integral wall being a continuous wall of substantially uniform thickness formed within the confines of the cylindrical body and integrally formed therewith, the apices lying substantially in a common plane substantially diametric to the valve body
  • the slits in valves used for medical devices are about 1.5 to about 2.5 mm long, but may be somewhat longer or shorter when used in other settings with longer or shorter or wider or narrower or thicker or thinner lands.
  • the apices are flattened in the form of lands.
  • the slits are formed or cut through the lands longitudinally thereof.
  • the one-way cross-slit valve is advantageously used in a low profile gastrostomy tube having an apertured dome or bulb with a sidewall of uniform thickness and with the middle of the bottom wall thereof surrounding the inner end of a hollow tubular shaft and there being a retention flange, usually with a removable plug or other closure, connected to and surrounding the outer end of the tubular shaft.
  • the valve may also be positioned at the outer end of the shaft, either adhesively bonded to the end of the shaft or mounted within an externally threaded shell that screws into an internally threaded well at the end of the shaft.
  • Fig. 1 is an isometric view of a low profile gastrostomy tube according to the prior art showing a hollow shaft with a perforated dome at the inner end of the shaft and with opposed wings or flanges at the outer end with a plug for the outer end of the shaft attached to one of the wings by a flexible membrane;
  • Fig. 2 is a fragmentary view in section of the dome and a portion of the inner end of the shaft of the device of Fig. 1 showing that the wall of the dome is of uniform thickness from apex to bottom wall, and, that there is within the dome a one-way flapper valve adapted to prevent the movement of any fluids out of the stomach into the shaft, and with the valve in the closed position;
  • Fig. 3 is a fragmentary view like that of Fig. 2 showing the flapper valve in the open position as it would be when pushed partly open by an obturator or if pushed by a flow of feeding fluid.
  • a valve may be defeated or rendered ineffective by tension placed on the dome, e.g., by patient weight gain thickening the body wall or by normal movement on the part of the patient;
  • Fig. 4 is an isometric view of another form of gastrostomy tube according to the prior art showing a hollow shaft with a conical dome joined at the inner end of the shaft and with a closure of the shaft at the outer end thereof;
  • Fig. 5 is a view in side elevation of the device of Fig. 4;
  • Fig. 6 is a view in longitudinal section of the device of Figs. 4 and 5 showing that the wall of the dome is of uniform thickness from the apex to the bottom wall, and, that the closure at the inner end of the shaft is a hollow threaded cap fitting within an extension of the retaining element that is attached around the outer end of the shaft, and that there is a simple duckbill valve within the threaded cap, but such valve being without intersecting ridges or slits or any surrounding hoop or cylinder;
  • Fig. 7 is a view in longitudinal section of yet another prior art gastrostomy device having a somewhat different shaped dome and with a one-way valve within the shaft and adjacent the dome, the one-way valve having a hemispherical valve element attached to a valve guide and seating into a hemispherical valve seat through which the valve stem extends;
  • Fig. 8 is an isometric view of yet another prior art low profile gastrostomy device having a hollow shaft with a dome attached at the inner end thereof and a perforated triangular retaining flange at the outer end thereof with an attached plug for closure of the shaft;
  • Fig. 9 is a view in end elevation of the device of Fig. 7 showing four apertures or perforations in the wall of the dome and a reinforced apex;
  • Fig. 10 is a fragmentary view in section of a portion of the inner end of the shaft and the attached dome of the device of Figs. 8 and 9, showing that the wall of the dome is of uniform thickness from apex to bottom wall and that a flapper valve is used as a one-way valve;
  • Fig. 11 is an isometric view of the novel low profile gastrostomy tube of the invention with a hollow tubular shaft with a retaining element and attached plug at one end and an apertured dome at the other;
  • Fig. 12 is a view in front elevation of the novel gastrostomy tube taken along the lines 12-12 of Fig. 11;
  • Fig. 13 is a view in rear elevation of the novel gastrostomy tube taken along the lines 13-13 of Fig. 11;
  • Fig. 14 is a view in longitudinal section of the novel gastrostomy tube of Fig. 11;
  • Fig.14A is a fragmentary portion of a view similar to Fig. 14 showing mainly the dome portion of the gastrostomy device of the invention with a different shaped dome and with the novel valve of the invention mounted therein;
  • Fig. 15 is an enlarged fragmentary view in section of the portion of Fig. 14 within the circle defined by the broken line;
  • Fig. 16 is an isometric view of the novel one-way cross-slit valve utilized in the present gastrostomy tube and by itself constituting another aspect of the invention, the novel valve being seen as a part of the device shown in Figs. 11 and 14;
  • Fig. 17 is a plan view of the valve shown separately in Fig. 16;
  • Fig. 18 is a view in section of the valve of Fig. 17 taken in the axial direction along the line 18-18;
  • Fig. 19 is a view in section of the valve of Fig. 17 taken in the axial direction along the line 19-19 that lies along a different diameter than followed in Fig. 18, in this case sectioning the land of one of the apices right along the slit therein so that the land does not appear in section except at the unslit portions near the cylindrical body wall;
  • Fig. 20 is a view in section of another embodiment of the present gastrostomy tube wherein the novel valve is positioned at the outer end of the tubular shaft, instead of within the dome.
  • the novel low profile gastrostomy tube of the invention is seen to comprise a tubular shaft, or connector tube, 31 with a retention element or flange 32, sometimes referred to as a retention disc, at its outer end 33, and a conventional hollow, apertured dome 34 at its inward end 35, all formed of an elasto eric material, such as a silicone rubber.
  • References herein to inner and outer end of the shaft are with reference to the disposition in the stoma of a patient.
  • the elastomeric material may be a composition of most any elastomer that is medically acceptable for use in the stoma of a patient and has the ability to promptly recover its natural state or shape after being deformed.
  • Silicone rubber and polyurethane are the preferred elastomers, with silicone rubber being most preferred; rubber latex and styrene-butadiene-rubber latex being less preferred.
  • the dome portion 34 is seen to have an apex 37, a sidewall 38 that is circular in section, and a bottom wall 39 opposite the apex, the bottom wall 39 being substantially planar except for the interruption of the communicating tubular shaft portion 31 and the bottom wall 39 being integrally formed with the sidewall 40 of the shaft portion 31 and substantially planar, although the bottom wall 39 may be adhesively bonded to the shaft portion, if desired.
  • the passageway 41 of the shaft portion 31 communicates with the interior of the dome portion 34, via the present novel one-way valve 42, the cylindrical valve body of which extends into the dome portion from about the bottom wall 39 of the dome portion where the valve is mounted on the inner end 35 of the tubular shaft portion 31.
  • the tubular shaft portion 31 will ordinarily have a length of from about 1.5 cm to about 4.3 cm, depending upon the patient in which the device is to be used.
  • the shaft diameter will be in the range of about 18 to about 28 French, i.e., 6 to 9.3 mm.
  • the sidewall 38 of the conventionally shaped dome portion 34 is of uniform thickness from adjacent the apex 37 to the bottom wall 39.
  • the dome portion 34 will generally run about 17.8 to about 21.6 mm in both overall height and width depending on whether the device is intended for use by an adult or a child.
  • the dome portion employed is often a bit taller than it is wide.
  • the dome portion is preferably substantially conical in shape.
  • the dome portion 34 is provided with three apertures 36 for the egress of fluids fed through the shaft portion 31, although a plurality of two to four or more apertures may be used, if desired.
  • the apertures 36 are preferably oval in shape and substantially equally spaced about the perimeter of the dome portion 34. Wherein these apertures 36 are oval, they each have their major axis lying approximately along a shortest line extending from the apex 37 to the bottom wall 39, with the lowest edge 43 of each aperture 36 adjacent the bottom wall 39 to aid in good fluid movement out of the dome portion, which is an advantage in that little residue of nutrient and other solutions administered are to be found in the dome portion after ordinary rinsing.
  • the size of the apertures 36 is not sharply critical.
  • the apertures should be large enough to permit ready dissemination of fluids injected through the shaft 31, but not so large as to prevent the dome 34 from performing its retention function, i.e., if there is insufficient sidewall between apertures the sidewall will be overly flexible.
  • the apertures are oval with the major axis longitudinal of the dome, the major axis having a length in the range of about 7.5 to 15 mm and the minor axis a length in the range of about 5 to 10 mm for a dome about 16.5 to 20.3 mm in height and width.
  • the length of the major axis will be in the range of about 7.6 to 12.7 mm and the length of the minor axis in the range of about 5 to 7.6 mm for a dome in this size range with three apertures.
  • the dome portion may take most any conical or mushroom shape that is circular in section, such as the dome 34a shown in the fragmentary view in section in Fig. 14A. Dome 34a is provided with four apertures 35a evenly spaced about the perimeter of the dome portion.
  • the novel valve 42 is positioned within the dome portion at the inward end 35 of shaft 31.
  • the outward end 33 of the shaft 31 of the gastrostomy tube 30 has integrally formed therewith a retention portion or flange 32 that bears against the skin of the patient when the device is in use and is preferably flat and more preferably triangular so that it can be rotated occasionally for care of the skin surrounding the site.
  • the flange 32 is perforated a plurality of times, for example three times, about equally spaced around the outer end 33 of the shaft 31 to permit some air to get to the skin surface.
  • the end 33 of the shaft 31 is conveniently closed by a plug 52.
  • the plug 52 is preferably attached to the flange 32 by a flexible membrane or tab 53 to avoid mislaying it.
  • the end portion 33 of the shaft 31 is preferably formed with an annular groove 54 in the passageway 41 to receive a complementary circumferential ridge 55 on the cylindrical portion 56 of the body 57 of the plug 52.
  • the one-way valve 42 is a slit valve of the novel design seen in Figs. 14 and 16-19.
  • the one-way cross-slit valve 42 is seated about the perimeter of the flanged end 49 thereof across the passageway opening 41a at about the bottom wall 39 of the dome portion 34 and provides positive, efficient one-way valve action to prevent reflux of intragastric fluids out of the gastrostomy tube while permitting ready passage of fluids such as nutrients into the stomach of the patient, or, allowing the passage of an obturator during insertion of the device.
  • the valve 42 is here seen in Figs. 16-19 to consist of a foreshortened hollow cylindrical body portion 44 having first and second ends 44a and 44b, and within which two substantially identical and mutually intersecting partially folded wall portions, indicated generally by the reference numerals 45 and 45a, each V-shaped in section, are each disposed at a right angle to the other to form a ridge and valley structure in which each wall portion meets, merges and joins with the other at each valley 48, there being four quadrants 47 and four valleys within the hollow cylindrical body portion 44 extending entirely across the passageway of the cylindrical body.
  • the partially folded wall portions 45,45a each extend substantially diametrically of the cylindrical body with the V's both opening in the same axial direction of the cylindrical body 44 i.e., towards the first end, and with the lines or lands 46, 46a each formed by a respective apex of a fold line of a partially folded wall portion 45, 45a extending along a plane diametrical and substantially normal to the wall of the cylindrical body 44 and each meeting and joining the other land at an angle of about 90 degrees at the center of curvature, i.e., the axis, of the cylindrical body 44 to form four quadrants 47 within the cylindrical body 44.
  • Each wall portion 45, 45a ends laterally midway around a quadrant where the wall portion meets, merges and is integrally joined to the other mutually intersecting wall portion to form a valley 48, four valleys in total, that each extend radially outwardly as well as away at an angle, generally, of about 50 to about 65 degrees from the plane in which the apices meet to form the lands 45, 45a, extending in the upstream direction of the shaft portion 31, that is, in the direction the valve will not permit fluids to move, which is also in the direction of the flange structure 49 at the first end of the cylindrical body 44.
  • the flange structure 49 facilitates adhesive bonding or otherwise attaching the cylindrical valve body 44 to the inward end 35 of shaft portion 31 with the valve within the hollow dome 34.
  • cylindrical valve body is about as wide as it is long.
  • each land 46, 46a is preferably flat and in said plane and each land is slit entirely through the wall thereof at the intersection thereof with the other land using a sharp instrument to produce very fine intersecting slits 50, 50a, each extending along a line about midway of the width of the land surface and about 60 to 80 percent, and preferably about 65 to 75 percent, of the radial length of the land from the intersection 51 of the slits 50, 50a to the wall of the cylindrical body 44.
  • the slit lengths are ordinarily in the range of about 1.5 to about 2.5 mm.
  • the width and thickness of the lands is also critical to the one-way valve operation if significant leakage is to be avoided. If the lands are too narrow or too thin, there is not sufficient integrity and serious leakage is likely to occur, while the size requirements of gastrostomy tubes limits the thickness of the folded walls that may be used forming the lands.
  • the width of each land should be, broadly, in the range of about 0.13 to 0.635 mm.
  • the width of the lands should be in the range of about 0.20 to 0.50 mm, more preferably about 0.25 to 0.46 mm.
  • the thickness of the lands should be about 0.127 to 0.762 mm, preferably in the range of about 0.254 to 0.635 mm, and more preferably about 0.381 to 0.635 mm.
  • the lands may be wider and thicker, for example, up to about 6.35 mm.
  • These dimensions are suitable for the valve when made of silicone rubber and may be increased or decreased somewhat depending on the strength and resiliency of the particular elastomer used in making up the valve, with the lower strength and less resilient elastomers requiring the use of somewhat increased dimensions.
  • the lands may be wider and thicker, if desired, for example, up to about 6.35 mm.
  • FIG. 18 there is shown to the left side the integrally formed valley 48 in section at a junction between the respective folded walls 45, 45a, then to the rear and in full, the next valley 48, and, to the right side the next valley 48 in section, the folded wall portions 45, 45a each being integrally formed with the wall of the cylindrical body portion 44.
  • a land 46a integrally formed with the wall of the cylindrical body portion 44 and sliced along the line of the sectional view exposing the thickness of the land, the slit 50a, seen also in Fig. 16, not extending the full diametric length of the land 46a.
  • the other land 46 that extends at right angles to the visible land 46a extends out of view back from the intersection 51 of the intersecting slit 50 at mid-width of the visible land 46a.
  • Each valley line 48 demarcates the junction of the folded wall 45a, of which the slitted land 46a is visible in this view, with the companion intersecting folded wall 45 that is hidden in this view.
  • the underside of the land nearly hidden 46 is aligned with the short line at 46b that appears in this view just below the intersecting slit 50 at intersection 51 and between the angularly extending folded wall portions 45a.
  • This construction of the operative valve portion of the cross-slit duckbill valve gives a very positive one-way valve action, greatly inhibiting the possibilities of reflux of intragastric fluids, while still facilitating the use of an obturator in elongating the dome of the device during insertion through a stoma as well as to accomplish decompression. Additionally, this valve construction permits ready introduction of fluids such as nutrient solutions or slurries.
  • the flange structure 49 also permits 360 degree adhesive attachment of the valve body 44 to the inward end 35 of shaft 31 with resulting significant reduction in the possibility of dislodging the novel slit valve from the end of the shaft as compared to dislodging a conventional, simpler flapper valve which can be attached at one side or end only.
  • the present valve may be utilized in the gastrostomy tube of the invention at the outward end 33 of the shaft 31 instead of within the dome portion 34 at the inward end 35 of the shaft 31.
  • the cylindrical body 44 of the valve may be inserted into the outward end or an end portion large enough to receive the valve body, and the flange structure 49 adhesively bonded to a step provided in the end face of the end 35 of shaft 31.
  • the cylindrical body 44 may be fitted into a retention flange 60 having a tubular extension 61 that surrounds and is adhesively bonded to the outward end 62 of shaft 63.
  • the tubular extension 61 is shaped to receive the flange structure 49 of the valve body 44, the flange structure 49 being adhesively bonded to the mouth of the tubular extension.
  • the cylindrical body 44 may also be mounted within the end of an externally threaded cylindrical sleeve such as that shown in the outward end of the device of Fig. 6 and the sleeve threaded into an internally threaded well that communicates with the shaft such as that shown in Fig. 6.
  • the one-way cross-slit valve has been described with particular emphasis to its use in gastrostomy tubes, it also finds use in other medical applications in injecting fluids into hollow organs or cavities of the human body where a one-way valve is needed or desired.
  • the one-way cross-slit valve also finds use in non-medical applications where there is a flow of a fluid from a reservoir or other supply means through a tube or supply line up to about 6.35 mm or even 12.7 mm in inner diameter and where one-way valve action is indicated or required. Examples where such valve may be used to advantage include a water supply line to an evaporative still, or a fuel line to a small engine or heater.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Check Valves (AREA)

Abstract

Une tube de gastrostomie (30) combine un dôme (34) et un arbre tubulaire (32) conventionnels avec une valve de non-retour en bec de canard à fente transversale (44). La valve de non-retour en forme de bec de canard est réalisée en un matériau élastomère et elle a un corps creux cylindrique avec une première et une seconde extrémités, un axe et un passage traversant le corps, le passage étant entièrement coupé par une structure de membrane ou de paroi avec des crêtes et des vallées faisant partie intégrante du corps cylindrique.
PCT/US1994/005221 1993-05-28 1994-05-11 Dispositif de gastrostomie avec une valve de non-retour fendue transversalement Ceased WO1994027656A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CA002162043A CA2162043C (fr) 1993-05-28 1994-05-11 Dispositif de gastrostomie avec distributeur a fente laterale unidirectionnel
EP94916731A EP0701454A4 (fr) 1993-05-28 1994-05-11 Dispositif de gastrostomie avec une valve de non-retour fendue transversalement

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US069,035 1979-08-23
US08/069,035 US5411491A (en) 1993-05-28 1993-05-28 Low profile gastrostomy device with one-way cross-slit valve

Publications (1)

Publication Number Publication Date
WO1994027656A1 true WO1994027656A1 (fr) 1994-12-08

Family

ID=22086308

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1994/005221 Ceased WO1994027656A1 (fr) 1993-05-28 1994-05-11 Dispositif de gastrostomie avec une valve de non-retour fendue transversalement

Country Status (4)

Country Link
US (1) US5411491A (fr)
EP (1) EP0701454A4 (fr)
CA (1) CA2162043C (fr)
WO (1) WO1994027656A1 (fr)

Cited By (1)

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US6077250A (en) * 1997-10-01 2000-06-20 Boston Scientific Corporation Apparatus and method for percutaneously placing gastrostomy tubes

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US5720734A (en) * 1994-02-28 1998-02-24 Wilson-Cook Medical, Inc. Gastrostomy feeding ports
US6019746A (en) * 1996-05-17 2000-02-01 Applied Medical Technology, Inc. Low profile balloon feeding device
US6464686B1 (en) * 1998-01-21 2002-10-15 Abbott Laboratories Polyurethane feeding tube and associated adaptors
USD418220S (en) * 1998-03-26 1999-12-28 Applied Medical Technology, Inc. Low profile balloon feeding device
FR2790950B1 (fr) 1999-03-15 2001-06-29 Thierry Scheye Dispositif d'abouchage d'un viscere creux a la peau
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CA2162043A1 (fr) 1994-12-08
EP0701454A1 (fr) 1996-03-20
EP0701454A4 (fr) 1996-05-08
CA2162043C (fr) 2000-06-20
US5411491A (en) 1995-05-02

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